Study to evaluate the safety and efficacy of nivolumab combined with ipilimumab as first-line (1L) therapy for participants with advanced HCC.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

3 Dec 2019 → ongoing

Decision date (initial)

2024-04-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-508635-31-00

EudraCT number

2019-000252-34

WHO UTN

U1111-1226-8182

ClinicalTrials.gov

NCT04039607

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Pharmacokinetic, Safety

The main purpose of this study is to compare the overall survival (OS) of
nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or
lenvatinib) in all randomized participants with advanced hepatocellular
carcinoma (HCC) who have not received prior systemic therapy.

Secondary objectives 3

1. To compare the ORR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab to SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy.
2. To evaluate DOR [as assessed by BICR based on RECIST 1.1] of nivolumab plus ipilimumab and SOC (sorafenib or lenvatinib) in all randomized participants with advanced HCC who have not received prior systemic therapy.
3. To compare the cancer-related symptom burden for participants randomized to nivolumab plus ipilimumab or SOC [sorafenib or lenvatinib]).

Conditions and MedDRA coding

Hepatocellular Carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participants must have a diagnosis of HCC based on histological confirmation
2. Participants must have an advanced HCC
3. Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
4. Child-Pugh score 5 or 6
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria 4

1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
2. Prior liver transplant
3. Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
4. Active brain metastases or leptomeningeal metastases

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. OS, defined as the time between the date of randomization and the date of death (by any cause).

Secondary endpoints 5

1. ORR, defined as the percentage of participants whose BOR is either a confirmed CR or PR.
2. DOR, defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first
3. TTSD, defined as the time from randomization until a clinically meaningful decline in the HCS subscale score of the FACT-Hep.
4. PFS, defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
5. TTP, defined as the time from randomization to the first documented disease progression.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 13

Locations

8 EU/EEA countries · 37 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 97 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications